Michael J. Morris and Dana Rathkopf, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY; R. Bryan Rumble, American Society of Clinical Oncology, Alexandria, VA; Ethan Basch and Matthew I. Milowsky, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Sebastien J. Hotte, Juravinski Cancer Centre, Hamilton; Andrew Loblaw, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Paul Celano, Greater Baltimore Medical Center, Towson, MD; and Rick Bangs, patient representative.
J Clin Oncol. 2018 May 20;36(15):1521-1539. doi: 10.1200/JCO.2018.78.0619. Epub 2018 Apr 2.
Purpose This clinical practice guideline addresses abiraterone or docetaxel with androgen-deprivation therapy (ADT) for metastatic prostate cancer that has not been treated (or has been minimally treated) with testosterone-lowering agents. Methods Standard therapy for newly diagnosed metastatic prostate cancer has been ADT alone. Three studies have compared ADT alone with ADT and docetaxel, and two studies have compared ADT alone with ADT and abiraterone. Results Three prospective randomized studies (GETUG-AFU 15, STAMPEDE, and CHAARTED) examined overall survival (OS) with adding docetaxel to ADT. STAMPEDE and CHAARTED favored docetaxel (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; n = 2,962 and HR, 0.73; 95% CI, 0.59 to 0.89; n = 790, respectively). GETUG-AFU 15 was negative. LATITUDE and STAMPEDE examined the impact on OS of adding abiraterone (with prednisone or prednisolone) to ADT. LATITUDE and STAMPEDE favored abiraterone (HR, 0.62; 95% CI, 0.51 to 0.76; n = 1,199 and HR, 0.63; 95% CI, 0.52 to 0.76; n = 1,917, respectively). Recommendations ADT plus docetaxel or abiraterone in newly diagnosed metastatic non-castrate prostate cancer offers a survival benefit as compared with ADT alone. The strongest evidence of benefit with docetaxel is in men with de novo high-volume (CHAARTED criteria) metastatic disease. Similar survival benefits are seen using abiraterone acetate in high-risk patients (LATITUDE criteria) and in the metastatic population in STAMPEDE. ADT plus abiraterone and ADT plus docetaxel have not been compared, and it is not known if some men benefit more from one regimen as opposed to the other. Fitness for chemotherapy, patient comorbidities, toxicity profiles, quality of life, drug availability, and cost should be considered in this decision. Additional information is available at www.asco.org/genitourinary-cancer-guidelines .
目的 本临床实践指南针对未接受(或仅接受最低限度治疗)睾丸激素降低剂治疗的转移性去势抵抗性前列腺癌,探讨阿比特龙或多西他赛联合去势治疗的疗效。
方法 新诊断的转移性前列腺癌的标准治疗是单独去势治疗。三项研究比较了单独去势治疗与去势治疗联合多西他赛的疗效,两项研究比较了单独去势治疗与去势治疗联合阿比特龙的疗效。
结果 三项前瞻性随机研究(GETUG-AFU 15、STAMPEDE 和 CHAARTED)均评估了联合多西他赛治疗对总生存期(OS)的影响。STAMPEDE 和 CHAARTED 研究结果均支持多西他赛(风险比[HR],0.78;95%CI,0.66 至 0.93;n=2962 和 HR,0.73;95%CI,0.59 至 0.89;n=790)。GETUG-AFU 15 研究结果为阴性。LATITUDE 和 STAMPEDE 研究评估了联合阿比特龙(联合泼尼松或强的松)治疗对 OS 的影响。LATITUDE 和 STAMPEDE 研究均支持阿比特龙(HR,0.62;95%CI,0.51 至 0.76;n=1199 和 HR,0.63;95%CI,0.52 至 0.76;n=1917)。
推荐意见 与单独去势治疗相比,新诊断的转移性非去势前列腺癌患者采用去势治疗联合多西他赛或阿比特龙可带来生存获益。对于新发高容量转移(CHAARTED 标准)疾病的患者,使用多西他赛获益的证据最强。高危患者(LATITUDE 标准)和 STAMPEDE 转移性人群中,使用醋酸阿比特龙也可观察到类似的生存获益。目前尚未比较阿比特龙联合去势治疗与多西他赛联合去势治疗的疗效,也不清楚某些患者是否从一种方案中获益更多,而不是从另一种方案中获益更多。在做出决策时,应考虑化疗的适应性、患者合并症、毒性谱、生活质量、药物可及性和成本。更多信息可在 www.asco.org/genitourinary-cancer-guidelines 获得。